Spain, through the European Union route · National competent authorities of the EU member states · New drugs
Review target
90 days
law
Legal time limit
-
Not published
Steps
5
9 requirements
Application fee
-
Used when a medicine already has a national marketing authorisation in one EU country and the holder wants it in other countries. The other countries recognise the existing authorisation based on the reference country's assessment report. Approval takes up to 90 days, then 30 days for national decisions. Medicines already authorised nationally in one EU country, outside the mandatory centralised scope.
The official review target is 90 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Reference country updates its assessment report (90 days); 2. Submission to the concerned member states; 3. Recognition phase (day 0 to day 90) (90 days); 4. Coordination group referral (if no agreement) (60 days); 5. National decisions (30 days).
Outcome: National marketing authorisations in the concerned countries with the same product information as the reference country.
Legal basis: Directive 2001/83/EC, Articles 28 and 29
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 270 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionlaw. Time for national decisions after agreement. | 30 days |
| Review targetlaw. Days for the concerned countries to approve the reference country's report. Official target days, not actual review times. Days the applicant spends answering questions do not count. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Centralised marketing authorisation, new active substance, Centralised marketing authorisation, known active substance or new fixed combination, Centralised generic application, Centralised hybrid application, Centralised well-established use application, Accelerated assessment, Conditional marketing authorisation, Authorisation under exceptional circumstances, PRIME (priority medicines), Orphan designation, Paediatric investigation plan, Integral drug-device combination authorised as a medicine, Decentralised procedure. See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.